Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral?

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Femur Fracture

Treatments: Drug: Paracetamol

Study type: Observational

Funder types: Other

Identifiers

NCT05025228

Prot. 36041/19 ID: 2727

Details and patient eligibility

About

The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR.

Full description

The investigators enrolled 170 consecutive patients with femur fracture and severe pain. The patients received an initial analgesic treatment with paracetamol orally (OR) or intravenously (IV). The primary outcome was the reduction of pain of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1). Secondary endpoints included the reduction of pain of at least 2 points on the VAS scale at the 4 th hour (T4), the need of rescue therapy and the number of adverse events.

Enrollment: 170 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Patients admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
• Femur Fracture
• Patients who signed the informed consent
• Able to take analgesic therapy both orally (OR) and intravenously (IV)
• Able to define pain by VAS

Exclusion criteria

• Age <18 years
• Allergy to paracetamol
• Unable to take analgesic therapy both orally (OR) and intravenously (IV)
• Unable to define pain by VAS

Trial design

170 participants in 2 patient groups

Paracetamol IV

Description:

Patients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV).

Treatment:

Drug: Paracetamol

Paracetamol OR

Description:

Patients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR).

Treatment:

Drug: Paracetamol